PROPEL corticosteroid‑releasing sinus implants — IBUKI cohort

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, standard‑of‑care cohort that collects real‑world data on Japanese patients treated with the PROPEL family of corticosteroid‑eluting implants following functional endoscopic sinus surgery (FESS). Patients are eligible if they have confirmed chronic rhinosinusitis, undergo uncomplicated FESS, and receive successful placement of 2–4 implants per the implant instructions for use. The study captures safety events, clinical performance, and patient‑reported sinonasal outcomes (including the 22‑item SNOT) through postoperative follow‑up, with data collected according to routine clinical visits. No experimental interventions are administered beyond standard care and the specified implant and packing requirements.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements

  * Patient has, or is intended to receive or be treated with, an eligible Medtronic product
  * Patient is consented within the enrollment window of the therapy received, as applicable
  * Patient has a confirmed diagnosis of CRS, and is indicated for FESS per Japan standard practice
  * FESS is successfully completed without the occurrence of major/significant complications that may confound study results
  * Successful placement of 2 to 4 corticosteroid-eluting implants in the ethmoid or frontal sinus (1 implant per sinus) in accordance with implant IFUs
  * NOVAPAK is the only hemostatic packing material placed bilaterally in ethmoid sinuses

Exclusion Criteria:

* Patient has clinical evidence of disease or a condition expected to compromise survival or ability to complete follow-up assessments through Month 6 (end of study)

  * Participation is excluded by local law
  * Patient is currently enrolled in, or plans to enroll in, any concurrent study that may confound the PSR results (i.e., no required intervention that could affect interpretation of all-around product safety and/or effectiveness)
  * Patient has received biologic medication approved for the treatment of CRSwNP (e.g., dupilumab, mepolizumab) in ≤ 12 weeks prior to the baseline/procedure visit
  * Patient is contraindicated in accordance with IFUs of PROPEL family implants and/or NOVAPAK

Where it's running

• Japanese Red Cross Asahikawa Hospital
  Asahikawa, Japan Recruiting

Study contacts

• Study coordinator: Katherine Schiller
• Email: katherine.schiller@medtronic.com
• Phone: 763-526-8329

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.